First site open for patient recruitment into
‘Kawasaki Disease Coronary Artery Aneurysm Prevention trial (KD-CAAP)’ Study
The first site is open to recruitment into one of the three inaugural studies
which will be utilising the infrastructure and resources of the conect4children network
The IMI conect4children (c4c) consortium are pleased to announce that the first site is now open for the ‘Kawasaki Disease Coronary Artery Aneurysm Prevention trial (KD-CAAP)’ study as of 28 September 2020 at Great Ormond Street Hospital NHS Foundation Trust.
Kawasaki disease is a disease where arteries, particularly the coronary arteries in the heart, become inflamed, sometimes causing irreversible heart damage, heart attacks or even death. To prevent heart damage, Kawasaki disease in children and young people must be recognised by clinicians early, and promptly treated with anti-inflammatory medicines.
This study will assess the effectiveness of adding steroids to standard treatment in children with Kawasaki Disease, and aims to recruit 262 children as part of the study. The study will continue to open in approximately 60 sites in 15 countries across Europe.
In April 2019, c4c announced the selection of its first portfolio of pan-European paediatric studies, aimed at advancing the understanding of high priority medicines commonly used in babies, children and young people in Europe. The KD-CAAP study is the first of the proof of viability studies, to begin recruitment. The other academic studies, shown below, plan to begin recruitment later this year, despite initial delays due to the COVID-19 pandemic.
- TREOCAPA Paracetamol in Premature Babies: will assess the effectiveness of paracetamol on the closure of the ductus arteriosus and the increase in surviving without severe morbidity of extreme premature infants. The study aims to recruit around 800 babies in 17 European countries. (Lead: Prof. Jean-Christophe Roze of INSERM, a public research organization in Paris, France entirely dedicated to human health
- cASPerCF Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. The study will assess the dose of posaconazole in children and young people with Cystic Fibrosis and Aspergillus infection and aims to recruit 135 children as part of the study (Lead: Prof Adilia Warris of the MRC Centre for Medical Mycology, University of Exeter, Sponsor: Ospedale Pediatrico Bambino Gesu (OPBG), a children’s hospital in Rome, Italy).
These studies will be the first to leverage the scientific quality, rigor and capabilities of the c4c network, a global consortium of more than 30 academics, 10 industry partners and a network of more than 500 affiliated partners.
The research collaboration will be used to build and implement a pan-European paediatric clinical trial network whose goal is to improve the European paediatric clinical trial infrastructure in order to facilitate the development of new, innovative and safer medicines for children in Europe.
Paul Brogan, KD-CAAP study sponsor, spoke about the value of the c4c consortium:
More information about each of the studies is available here:
About Innovative Medicines Initiative and c4c
The c4c project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU), Europe’s biggest Public-Private Partnership, under grant agreement No 777389. The JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA (the European Federation of Pharmaceutical Industries and Association).
Under the name c4c, the new research consortium unites pharmaceutical companies, paediatric national networks as well as EU Multinational sub-specialty Networks, large patient advocacy groups, children’s hospitals and other public research organisations from across Europe.
The full list of organisations involved in the project can be found at the c4c webpage www.conect4children.org.
For more info on IMI visit www.imi.europa.eu and follow on Twitter at @IMI_JU.
Project Office/General Enquires: Email us. firstname.lastname@example.org
For more information about the research studies, contact:
- INSERM (France): Jean Christophe Roze email@example.com
- UCL (UK): Despina Eleftheriou firstname.lastname@example.org
- OPBG (Italy): Adilia Warris email@example.com
This communication reflects the views of the c4c Consortium only and neither IMI nor the European Union and EFPIA are liable for any use that may be made of the information contained herein
H2020-JTI-IMI2-2016-10. Proposal: 77738